Impax Laboratories Inc., a specialty pharmaceutical company, has announced a reorganization of its research and development (R&D) organizations and a prioritization of the project portfolios within its generic and brand businesses. The reorganization will result in a net reduction of approximately 49 positions, including 42 in R&D, or about 25% of the combined brand and generic R&D organizations.

As a result of the reorganization, the generic R&D organization will be responsible for early-stage product development and analytical functions for all Impax products while the brand R&D organization will focus on Phase II, III, and IV clinical activities, drug safety, and pharmacovigilance for all Impax products.

​The company expects to realize approximately $8.0 million of annual cost savings beginning in 2015 and approximately $1.5 million in the fourth quarter of 2014. In the fourth quarter 2014, the company expects to record certain charges of about $2.0 million associated with the reorganization. 

In its generics portfolio, the company has 23 abbreviated new drug applications pending at the US Food and Drug Administration (FDA) and 23 projects under development. This includes four pending ANDAs and nine projects under development that are alternative dosage form products through external collaborations.

Its branded portfolio consists of Rytary, an extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson’s disease. A new drug application is pending at the FDA with a Prescription Drug User Fee Act (PDUFA) review date of January 9, 2015. The company is also planning to file a marketing authorization application in Europe by the end of 2014.

Other branded products are IPX239, an investigational transdermal bupivacaine patch for the treatment of pain associated with post-herpetic neuralgia (PHN) licensed from the specialty pharmaceutical company, Durect Corporation, and IPX203, an investigational drug for the symptomatic treatment of Parkinson’s disease. The company recently filed an Investigational new drug application with the FDA.   

Source: Impax Laboratories